First-line hepatitis C therapy which
includes a protease inhibitor can be cost-effective, investigators show in the Annals of Internal Medicine. The study
showed that a triple combination of drugs, including the cheaper of the
newly licensed protease inhibitors, was most cost-effective after screening for
a gene mutation associated with response to hepatitis C treatment for patients with
“Our study supports the important role of
protease inhibitors in treating chronic HCV [hepatitis C virus] for patients
with advanced fibrosis as part of a first-line regimen,” write the authors.
Standard therapy for hepatitis C consists
of pegylated interferon and ribavirin. This achieves a cure in between 40 and
60% of patients chronically infected with hepatitis C genotype 1. Poorer
response rates are seen in patients with HIV.
Quality adjusted life year. Used in studies dealing with cost-effectiveness and life expectancy, this gives a higher value to a year lived with good health than a year lived with poor health, pain or disability.
inhibitors have recently been approved for the treatment of hepatitis C
genotype 1 infection. In clinical trials, a higher proportion of patients who
received boceprevir (Victrelis) or
telaprevir (Incivek / Incivo) in combination
with standard therapy achieved a sustained virological response (an
undetectable hepatitis C viral load six months after the completion of therapy,
defined as a cure), compared to patients who received standard therapy.
new drugs are expensive. Each week of treatment with boceprevir costs US$1100 and
telaprevir costs $4100 per week. This expense raises important
questions about the therapies’ cost-effectiveness. The presence of a mutation in the IL-28B
gene has been associated with improved hepatitis C treatment responses and
screening for this mutation could help target patients most likely to benefit
Therefore a team
of investigators developed a model to establish the cost of each
quality-adjusted life-year (QALY) associated with the drugs.
Their model was
based on the assumption that the drugs would have the same 'real world'
efficacy as they demonstrated in clinical trials, and that 70% of patients
would take at least 80% of their doses.
models also took into account patient health. The cost-effectiveness of each
drug was calculated according to whether individuals had mild or severe liver
treatment strategies were included in the model. In the first, therapy was
targeted at patients with the favourable IL-28B genotype; in the second, universal therapy was
The model was
based on the assumption that the cheaper protease inhibitor would be used and
also took into account the costs of existing hepatitis C treatment.
Using a protease
inhibitor was shown to have real benefits. The provision of universal
triple-drug therapy for patients with advanced fibrosis increased the
proportion achieving a sustained virological response to 51%, compared to the
32% rate seen with standard treatment. For patients with mild fibrosis the
proportion achieving a sustained virological response increased from 38 to
61%. IL-28B-guided treatment achieved a sustained virological response in 48%
of patients with advanced fibrosis and 57% of those with mild fibrosis. The
improved treatment response rates achieved with the inclusion of a protease
inhibitor significantly reduced the chance of decompensated liver disease,
liver cancer and the need for a liver transplant.
But a substantial
financial cost accompanied these improved response rates. Compared to standard
treatment, the addition of a protease inhibitor increased the cost of therapy
for patients with advanced fibrosis by $24,000 and for patients with mild
fibrosis by $22,000.
investigators’ calculation showed that triple-drug treatment would still be
cost effective in some circumstances.
For patients with
advanced fibrosis, IL-28B-guided treatment cost $32, 800 per QALY. This
increased to $51,500 for universal therapy. For individuals with mild fibrosis,
IL-28B guided therapy had a cost of $62,900 per QALY, with universal therapy
entailing a cost of $102,600 per QALY.
“Although it also
increases total costs, universal triple therapy provides reasonable value for money,
costing approximately $50 000 per QALY compared with IL-28B-guided therapy for
patients with advanced fibrosis,” write the authors. However, the cost-effectiveness of this strategy depended on fibrosis stage. “For patients with
mild fibrosis, universal triple therapy at a cost of $1100 per week is not cost-effective, even at $100,000 per QALY, but IL-28B-guided triple therapy costs
$62,900 per QALY compared with standard therapy.”
mean that the real costs were substantially lower. For instance, the Veterans
Health Administration is able to purchase drugs at the Federal Supply Schedule
Poor adherence to
protease inhibitor therapy could reduce the cost-effectiveness of treatment.
“Universal triple therapy becomes less cost-effective when the cost of protease
inhibitors is higher, or when adherence rates are substantially lower for triple
therapy than for standard therapy.”
conclude: “Management of chronic HCV in the United States could be improved by
a shift toward response-guided triple-drug strategies, provided that the price
of protease inhibitors and adherence to taking them are maintained at a